Quad Pharma cc

Quad Pharma cc We specialise in Regulatory and GMP training for the pharmaceutical industry in South Africa.

Due to clashes with the elections and some industry meetings we have made slight adjustments to the dates for some of ou...
13/03/2024

Due to clashes with the elections and some industry meetings we have made slight adjustments to the dates for some of our courses. The new dates are underlined in the attached calendar.

22/01/2024

ALL COURSES WILL CONTINUE ONLINE using live video except for eCTD Skills training which may be either online if you have the required software or face to face. By exception any delegates who have poor internet connectivity can, by special request, participate in the training using the facilities at the Quad Office.
eCTD Skills and NeeS -2 days (Johannesburg) Face to face or on-line if you have the software. Feb 12-13, 22-23 May, 2-3 Sep, 4-5 Nov
MEDICINES REGISTRATION BASIC: Registered short course: Enterprise Standards 1,2 & 3; (MAX 4 delegates) 4.5 Days 22-26 Jan(FULL), 19-23 Feb, 11-15 Mar, 15-19 Apr, 13-17 May, 10-14 Jun, 22-26 Jul, 19-23 Aug, 16-10 Sep, 21-25 Oct, 18-22 Nov.
MEDICINES REGISTRATION FOR REGISTRATION ASSISTANTS: Enterprise Standard 1:(Max 4 delegates) 4.5 days 24-28 Jun
The Clinical and Non-Clinical Dossier Enterprise Standard 4 Registered Short course; 3 DAYS (1 - 4 delegates) 23-25 May
MEDICINES REGISTRATION FOR BIOLOGICAL MEDICINES: Enterprise standard 5: Registered Short course; 3 DAYS (1 - 4 delegates) 5-7 Mar, 27-29 Aug, Registration of Biosimilars & Bio-comparability one-day workshop. On request
The Responsible Pharmacist in Industry 2-days 15-16 Jan,10-11 Apr, 17-18 Jul, 16-17 Oct
Responsible Pharmacist Refresher – ½ day On request
Variations-EMA guide workshop 1 day 3 Apr 9 Jul 1 Oct
PI and PIL Workshop. (SmPC and variations to PI/PIL) 1 day 4 Apr 10 Jul 2 Oct
SUB SAHARAN AFRICA Medicine Registration - 2 day workshop- 26-27 Feb, 28-29 May, 5-6 Aug, 6-7 Nov
Effective Pharmacovigilance- 1 day 5 FEB, 9 May, 1 Aug 12 Nov
The Effective Company Code Compliance Officer - ½ day 1 Feb, 11 Jul, 14 Nov
SAHPRA INSPECTIONS: 1 day 17Jan, 8 Apr, 15 Jul, 14 Oct
GMP FOR IMPORTERS 1 day 18 Jan, 9 Apr, 16Jul, 15 Oct
MASTER DOCUMENTS: Morning workshop 19 Jan, 12 Apr, 19 Jul, 18 Oct
Audit of third-party manufacturers (non-sterile) 6 Feb, 7 May, 10 Sep, 26 Nov
Audit of Sterile manufacturers 7 Feb, 8 May,11 Sep, 27 Nov

Date changes in JULY for Quad Pharma training. Due to unforeseen circumstances, the following course dates have had to c...
09/05/2023

Date changes in JULY for Quad Pharma training. Due to unforeseen circumstances, the following course dates have had to change.
Responsible Pharmacist has been moved a week earlier to 5-6 July
Master documents from 14th to 3rd July.
Please let your colleagues know. For Information on all quad Pharma courses please visit

AUDIT/Inspection of 3rd Party Manufacturers and Audit/Inspection of 3rd Party Sterile Manufacturers – June and October.

12/02/2022

eCTD -eQALs the affordable South African Solution for eCTD.
The deadline for eCTD only submissions is 31 March 2022.
eQALs is a South African developed affordable eCTD solution already used by companies and consultants alike.
If you thought eCTD software was unaffordable and out of reach for you, think again, think eQALs our very own affordable South African solution.

SAHPRA Communication 12 October 2021

The purpose of this document is to provide an update to all applicants regarding the eCTD implementation roadmap and the revised deadline. Reference is made to a SAHPRA-ITG working group meeting, held on the 06th of August 2021, where the eCTD Implementation Roadmap was further discussed and an extension to take us through to 31 March 2022, was communicated.

10/12/2021

For close friends. I have some very personal reasons for this post. It is in the hardest moments in life that you realize who your real family, friends or people are really interested in you. People's true colors come out if attention is not on them. Unfortunately, some friends will press ''likes'' but they really don't read it because it takes time to read this statement and when they see it's long, they skip it. Now I am looking at those who take the time to read this post until the end..... (I think I will figure out 5 maybe 6 will). Maybe some of you like me and some don't, but if you're on my Facebook, it's because I like you. I would like to see if we can chat even more and write something for each other. I decided to participate in an experience called ''Breadbread Encounter'. The idea is to see who reads posts without a photo. We are so consumed with technology that we forget the most important thing: good friendships. If no one reads this post, it will be a short social experiment. But if you finish reading this to the end, I would like you to comment on us in one word. For example: a place, an object, a person, a time when you remember me. Then copy this text and post it to your page (don't share) I'll go to your page to leave a word that reminds me of you. Please don't comment if you don't have time to copy the text. This will destroy the experiment. Let's see who spent their time reading and reacting according to general story on Facebook! Thank you for participating! The power of unity!! To everyone who has lost someone or is in battle, here is a hug for each of you and your loved ones!
Let's see what happens!

25/03/2020

LOCK-DOWN is forcing us to think out of the box and use different training methods.
For some scheduled courses we will be using on-line training but only for those who want to participate in this way.
For those who are unable OR uncomfortable using the online method we are rescheduling training dates to accommodate them.
VARIATIONS TRAINING WORKSHOP scheduled for 15th April has been postponed to 30th April

20/02/2020

RP Refresher Workshop: 23 March 2020
Target Audience:
This is a one day workshop aimed at the experienced RP/DRP/Senior Pharmacists involved in QA/RA.
Candidates need to have completed the QuadPharma RP Course or have been an RP/DRP/Senior QA/RA Management Role for three years.
The workshop focuses on managing the RP role rather than technical content.
Objectives:
1. Consolidate understanding of the RP role
2. Verify that you are meeting the latest requirements with regard to QA and RA
3. Refresh and summarise knowledge on recent changes from SAHPRA
Topics covered:
1. Changes at SAHPRA and what they mean for the RP
2. Revised regulatory requirements and how to manage them
3. Making QMR (Quality Management Review) work for you and how to make use of quality metrics
4. Risk Management requirements and strategies
5. Audit requirements and how to manage auditing
6. Conflict management and negotiation skills

TRAINING CALENDAR 2020 FIRST QUARTER
06/01/2020

TRAINING CALENDAR 2020 FIRST QUARTER

06/11/2019

SAHPRA INSPECTIONS: 18 November 2019
The requirements and implications of the different types of inspections performed by MCC and PIC/S inspections will be covered.
Legal aspects in terms of The Pharmacy Act, The Medicines Control Act 101 as amended.
Licensing requirements, powers of inspectors and the functions of a Pharmaceutical Operation.
Presenter: Katrin Stulpner
Time: 8:30 – 16:00
Venue: Quad Pharma cc
63 Forest Road
Bramley, Johannesburg

GMP FOR IMPORTERS: 19 November 2019
GMP and PIC standards. Auditing: -Factory, Packer, Laboratory Distributor, Printer, Auditing Systems
Contracts and SOP’s.
Validation of Transport.
Documentation
Presenter: Katrin Stulpner
Time: 8:30 – 16:00
Venue: Quad Pharma cc
63 Forest Road
Bramley, Johannesburg

18/10/2019

Quad Pharma cc Targeted Training
Final courses for 2019 Please visit www.quadpharma.com for more information or contact courses@quadpharma.com
The Responsible Pharmacist in Industry 5 – 6 November
SUB SAHARAN AFRICA Medicine Registration - 2 day workshop- 12-13 November
SAHPRA INSPECTIONS: 18 November
GMP FOR IMPORTERS: 19 November
eCTD Skills and NeeS (eSubmission) 20-21 November

15/10/2019

Targeted Training November
SAHPRA INSPECTIONS: 18 November 2019

The requirements and implications of the different types of inspections performed by MCC and PIC/S inspections will be covered.

Legal aspects in terms of The Pharmacy Act, The Medicines Control Act 101 as amended.

Licensing requirements, powers of inspectors and the functions of a Pharmaceutical Operation.

Presenter: Katrin Stulpner

Time: 8:30 – 16:00

Venue: Quad Pharma cc

63 Forest Road

Bramley, Johannesburg

GMP FOR IMPORTERS: 19 November 2019

GMP and PIC standards. Auditing: -Factory, Packer, Laboratory Distributor, Printer, Auditing Systems

Contracts and SOP’s.

Validation of Transport.

Documentation

Presenter: Katrin Stulpner

Time: 8:30 – 16:00

Venue: Quad Pharma cc

63 Forest Road

Bramley, Johannesburg

Address

63 Forest Road Bramley
Johannesburg
2090

Opening Hours

Monday 09:00 - 16:00
Tuesday 09:00 - 16:00
Wednesday 09:00 - 16:00
Thursday 09:00 - 16:00
Friday 09:00 - 12:30

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